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Reusable Leg Belt- 32mm X 15M

by Philips Medizin Systeme Böblingen GmbH

Ref M4601A

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00884838116498 UDI-DI Date24 Jan 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0884838BM1631MJ Basic UDI-DI 00884838116498UDI-DIDate21 Jan 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Reusable Leg Belt- 32mm X 15M EUDAMED
Fetal Measurements GUDID
Generic Name
Electrode/transducer strap, reusable
Device Name
Disposable and reusable fetal belts
Model / Ref / Catalog
M4601A, REUSABLE LEG BELT- 32MM X 15M
Primary DI / UDI-DI
00884838116498
Basic UDI-DI
0884838BM1631MJ
FDA Product Code
HGM
EMDN Code
Z12080101 Foetal monitors
GMDN Term
Electrode/transducer strap, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
884.2740
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
M4601A
GUDID
REUSABLE LEG BELT- 32MM X 15M
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Other devices from Philips Medizin Systeme Böblingen GmbH

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No